1. Field of the Invention
The present invention relates to a method of inhibiting blood platelet aggregation in humans, as well as to a method of therapeutically treating human disease conditions associated with blood platelet aggregation. The invention also pertains to a method of stimulating the immune system, and to a method of therapeutically treating immune system disorders.
2. Description of the Prior Art
Platelets are the smallest of the formed elements of the blood. Every cubic millimeter of blood contains about 250 million platelets, as compared with only a few thousand white cells. There are about a trillion platelets in the blood of an average human adult. Platelets are not cells, but are fragments of the giant bone-marrow cells called megakaryocytes. When a megakaryocyte matures, its cytoplasm breaks up, forming several thousand platelets. Platelets lack DNA and have little ability to synthesize proteins. When released into the blood, they circulate and die in about ten days. However, platelets do possess an active metabolism to supply their energy needs.
Because platelets contain a generous amount of contractile protein (actomyosin), they are prone to contract much as muscles do. This phenomenon explains the shrinkage of a fresh blood clot after it stands for only a few minutes. The shrinkage plays a role in forming a hemostatic plug when a blood vessel is cut. The primary function of platelets is that of forming blood clots. When a wound occurs, platelets are attracted to the site where they activate a substance (thrombin) which starts the clotting process. Thrombin, in addition to converting fibrinogen into fibrin, also makes the platelets sticky. Thus, when exposed to collagen and thrombin, the platelets aggregate to form a plug in the hole of an injured blood vessel.
Platelets not only tend to stick to one another, but to the walls of blood vessels as well. Because they promote clotting, platelets have a key role in the formation of thrombi. The dangerous consequences of thrombi are evident in many cardiovascular and cerebrovascular disorders.
In this regard, the precise function of blood platelets in various human disease states has recently become increasingly understood as advances in biochemistry permit the etiologies of diseases to be better understood.
For example, many attempts have been made to explain the process of atherogenesis, that is, the creation of plaque which narrows arteries and, of particular concern, the coronary arteries. Recently, there has been increasing interest in the possible role of platelets in atherosclerosis.
In addition, a number of disease states in humans are believed to be associated with an aggregation of platelets in the blood. These platelet aggregation associated conditions include: peripheral vascular disease; thrombotic diseases such as coronary thrombosis and pulmonary thrombosis; stroke; eclampsia and pre-eclampsia; and hypertension.
A study completed by the University of Oxford, England, and published in the British Medical Journal, Vol. 296, Jan. 30 1988, pages 320-331, entitled "Secondary Prevention of Vascular Disease by Prolonged Antiplatelet Treatment," suggests that therapies which inhibit platelet aggregation may be useful for treating occlusive vascular disease. The study utilized aspirin, sulphinpyrazone, or aspirin and dipyridamole as the platelet aggregation inhibiting agents.
Unfortunately, long-term aspirin therapy may lead to severe gastrointestinal irritation and bleeding. Also, these and other known agents which inhibit platelet aggregation may have other undesirable side-effects that make them unsuitable for administration to patients who could benefit from such therapy. For pregnant women with pre-eclampsia or other platelet aggregation associated conditions, the administration of drugs may be undesirable in view of the potential effects of the same on the developing fetus.
It would therefore be desirable to provide a method of inhibiting blood platelet aggregation which overcomes the deficiencies of the prior art.
A separate body of prior art discloses various methods of using ozone gas to treat certain human diseases, wounds and infections:
U.S. Pat. No. 695,657 to Smith discloses a portable ozonizer for the treatment of wounds. The device includes an ozonizer housed in a glass jacket, one end of which receives an air-supply tube and other end of which functions as an outlet tube for the ozonized air. The device enables topical application of ozone gas, which is said to be used to treat suppurating or gangrenous surfaces.
U.S. Pat. No. 3,715,430 to Ryan relates to a method and apparatus for producing substantially pure oxygen having a controlled content of ozone and higher oxygen polymers. The purified oxygen gas is exposed to ultraviolet light in a wavelength of 2485 to 2537 angstrom units in order to produce 5 to 500 parts per million of ozone and higher oxygen polymers in the gas mixture. Ryan indicates that the gas produced in this manner is non-irritating to the human body and may be intravenously injected into the blood stream for therapeutic use.
U.S. Pat. No. 4,632,980 to Zee et al. discloses a method of freeing blood and blood components of enveloped viruses by contacting the blood or blood product in an aqueous medium with an enveloped virus inactivating amount of ozone. The treatment is carried out at a temperature of 4.degree. to 37.degree. C., and an ozone concentration of 1-100 ppm. The disclosed process is said to useful for inactivating the hepatitis virus, HTLV-I, -II, and -III, and influenza virus.
U.S. Pat. No. 4,831,268 to Fisch et al. provides a method for the radiation of corporeal blood to prevent arteriosclerosis related heart and vascular diseases caused by disturbances in the fat exchange. The disclosed process involves irradiating the blood in a blood conducting tube with radiation having an intensity of from about 1 mWcm.sup.-2 to 10 mWcm.sup.-2 in a wavelength range of from about 320 nm to 600 nm.
U.S. Pat. No. 4,968,483 to Muller et al. discloses an apparatus for the production of oxygenated blood. The apparatus includes a vessel for containing the blood to be processed, an ultraviolet lamp and infrared lamp associated with the vessel, and a feed pipe extending into the vessel to a position near the bottom of the vessel, in which the feed pipe is connected to a source of ozone.
U.S. Pat. No. 4,983,637 to Herman relates to a method of treating systemic viral infections by the parenteral administration of pharmacologically effective amounts of ozonides of terpenes in pharmaceutically acceptable carriers. The disclosed method is particularly directed to the treatment of HIV infections.
U.S. Pat. No. 5,052,382 to Wainwright discloses an apparatus for the controlled generation and administration of ozone. The apparatus includes a generator for generating ozone, a monitor for monitoring the ozone production, a dosage device for providing a predetermined amount of ozone administration, and a computer control device for controlling the operation of the apparatus. The patent further discloses that administration of ozone to patients is known for the treatment of viral and bacterial infections, as well as for the treatment of external sores and wounds.